Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:24 AM
Study NCT ID:
NCT07333261
Status:
RECRUITING
Last Update Posted:
2026-02-13
First Post:
2025-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of BMS-986453 in Newly Diagnosed Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a single center, open-label, Phase 1b study to determine the safety, and preliminary efficacy of BMS-986453, a dual targeting CAR-T cell product targeting BCMA and GPRC5D, in participants with NDMM in whom ASCT is not planned.\n\nThe study will evaluate the safety, PK, pharmacodynamic, and preliminary efficacy of BMS-986453 at the RP2D. All treated participants will complete three periods: pre-treatment, treatment, and post- treatment follow-up.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2041-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-11', 'studyFirstSubmitDate': '2025-12-02', 'studyFirstSubmitQcDate': '2025-12-29', 'lastUpdatePostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v5.0', 'timeFrame': 'Baseline up to 5 years', 'description': 'Evaluate the safety and tolerability of BMS-986453 in participants with NDMM.'}], 'secondaryOutcomes': [{'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'Baseline up to 5 years', 'description': 'Measure of clinical response.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Baseline up to 5 years', 'description': 'Measure of clinical response.'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Baseline up to 5 years', 'description': 'Measure of clinical response.'}, {'measure': 'Pharmacokinetics (PK)', 'timeFrame': 'Baseline up to 2 years', 'description': 'Measures of observed blood concentration of BMS-968453.'}, {'measure': 'Complete response rate', 'timeFrame': 'Baseline up to 5 years', 'description': 'Measures of clinical response.'}, {'measure': 'MRD negativity', 'timeFrame': 'Baseline up to 5 years', 'description': 'Proportion of participants with overall MRD negativity, 9-month MRD negativity rates as well as sustained (\\>12 months) MRD negativity.'}, {'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v5.0', 'timeFrame': 'Up to 15 years', 'description': 'Assess long-term toxicity'}, {'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v5.0', 'timeFrame': 'Up to 15 years', 'description': 'Assess lentiviral vector safety'}, {'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v5.0', 'timeFrame': 'Up to 15 years', 'description': 'Assess disease status'}, {'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v5.0', 'timeFrame': 'Up to 15 years', 'description': 'Assess survival after BMS-968453 infusion'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'This is a phase 1b study evaluating if BMS-986453 is safe and effective in treating people who have newly diagnosed multiple myeloma after completing initial therapy (induction) when a stem cell transplant is not intended.', 'detailedDescription': 'This is an open-label study. The investigators propose to examine if BMS-986453 in people with newly diagnosed multiple myeloma may help control their disease for a prolonged period of time despite one-time treatment and challenge continuous treatment which is otherwise prescribed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age \\> 18 years with no upper age limit\n2. NDMM with indication for initiation of therapy diagnosed within last 12 months. Pretreatment parameters necessary for disease characterization and response assessment must be available.\n3. Not eligible for ASCT by institutional criteria or deferring ASCT due to personal preference.\n4. ECOG performance status 0-1\n5. Adequate organ function\n\nExclusion Criteria:\n\n1. Known active or history of central nervous system (CNS) involvement of MM.\n2. Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS or clinically significant amiloidosis.\n3. Prior history of other malignancies\n4. Uncontrolled infection\n\nOther protocol-defined Inclusion/Exclusion criteria apply."}, 'identificationModule': {'nctId': 'NCT07333261', 'briefTitle': 'Study of BMS-986453 in Newly Diagnosed Multiple Myeloma', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'A Phase 1b Study of BMS-986453, Dual Targeting BCMAxGPRC5D Chimeric Antigen Receptor T Cells, in Participants With Newly Diagnosed Multiple Myeloma', 'orgStudyIdInfo': {'id': 'IRB-300015643 (UAB2595)'}, 'secondaryIdInfos': [{'id': '000551303', 'type': 'OTHER', 'domain': 'BMS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single dose BMS-986453', 'description': 'Participants will be treated with fludarabine IV (30 mg/m2/day) and cyclophosphamide IV (300 mg/m2/day) for 3 days prior to BMS-986453 infusion.\n\nA single dose of BMS-986453 administered by IV infusion.', 'interventionNames': ['Drug: BMS-986453']}], 'interventions': [{'name': 'BMS-986453', 'type': 'DRUG', 'description': 'Will be given as a single dose administered by IV infusion.', 'armGroupLabels': ['Single dose BMS-986453']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Susan Bal, MD', 'role': 'CONTACT', 'email': 'susanbal@uabmc.edu', 'phone': '2059347645'}, {'name': 'Luciano J Costa, MD, PhD', 'role': 'CONTACT', 'email': 'ljcosta@uabmc.edu'}, {'name': 'Susan Bal, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Luciano J Costa, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kelly Godby, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Gayathri Ravi, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Heidi Worth, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'centralContacts': [{'name': 'Susan Bal, MD', 'role': 'CONTACT', 'email': 'susanbal@uabmc.edu', 'phone': '(205) 934-7645'}, {'name': 'Margaret Thomas, MPH', 'role': 'CONTACT', 'email': 'margaretathomas@uabmc.edu'}], 'overallOfficials': [{'name': 'Susan Bal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Alabama at Birmingham'}, {'name': 'Luciano A Costa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Susan Bal', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Susan Bal', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}